FDA Device recall Z-1537-2024
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only by Masimo, citing their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1537-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-15 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Masimo |
| Distribution | US |
Product
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Reason
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Identifiers
| code_info | UDI:(01)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 60…UDI:(01)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 6000062126 6000062127 6000062128 6000062129 6000062130 6000062131 6000062132 6000062133 6000062134 6000062135 6000062136 6000062137 6000062138 6000062139 6000062140 6000062141 6000062142 6000062143 6000062144 6000062145 6000062146 6000062147 6000062148 6000062149 6000062150 6000062151 6000062152 6000062153 6000062154 6000062155 6000062156 6000062157 6000062158 6000062159 6000062160 6000062161 6000062162 6000062163 6000062164 6000062165 6000062166 6000062167 6000062168 6000062169 6000062170 6000062171 6000062172 6000062173 6000062174 6000062175 6000062176 6000062177 6000062178 6000062179 6000062180 6000062181 6000062182 6000062183 6000062184 6000062185 6000062186 6000062187 6000062188 6000062189 6000062190 6000062191 6000062192 6000062194 6000062195 6000062196 6000062197 6000062198 6000062199 6000062200 6000062201 6000062202 6000062203 6000062204 6000062205 6000062206 600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1537-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.